Evaluation of Accuracy and Consistency of the X-Trodes System

Completed

Conditions studied: Equipment and Supplies

In brief

The purpose of this study is to evaluate the accuracy and consistency of the X-Trodes acquisition system compared to a Food and Drug Administration (FDA)-cleared clinical electrophysiology device.

Key facts

Study ID

NCT05722639

Run by

B-Cube

People needed

57

Starts

2023-01-23

Expected to finish

2024-01-04

Last updated by the study team

2024-03-01

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• To be included in the study, subjects must meet all the following inclusion criteria:
• Adults (age 21 - 99)
• Referred to an electrophysiology test by either neurologist or cardiologist in the last 5 years
• Produce interpretable electrophysiological signals by the acquisition devices

You may not qualify if…

• Did not sign the informed consent
• Cannot maintain the electrodes attached to their skin (i.e., due to beard on the chin area)
• Diagnosed as suffering from sleep apnea
• Pregnant or lactating women

Where it is running

• B-Cube — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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